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Cole Werble

Washington, DC
Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.

Latest From Cole Werble

The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA

Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.

FDA Leadership

AAV Vector Consortia Address Quality Assays, Endpoints

Two outside groups aim to help CBER on gene therapy questions from ‘N of one’ to markers for hemophilia.

Gene Therapy Drug Approval Standards

Patent Thickets And Legislative Logjams

US Senate hearing on pharmaceutical competition brought renewed interest to idea of pruning so-called ‘patent thickets.’ But the choking growth of legislative proposals may itself by hampering progress on Capitol Hill.

Intellectual Property Biosimilars

Biden Administration Will Back New Health Research Contracting Agency

Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.

Research & Development Politics

COVID Vaccine ‘Miracle’ May Set Unrealistic Expectations For US Supply Chains

The story of the US coronavirus vaccine production ramp-up is putting the drug industry in an extraordinarily favorable public relations position. One downside, however, may be complicating the industry’s message about the limits of ‘Buy American’ efforts on pharmaceutical supply chains overall.

Manufacturing Politics

COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA

COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.

Coronavirus COVID-19 Clinical Trials
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